Foreign matter has been discovered in five unused vials of Pfizer’s COVID-19 vaccine near Tokyo, Japan, and one vial in Osaka Prefecture, officials said on Tuesday.
Officials told Kyodo that contaminants were found in several sites in Sagamihara, one site in Kamakura, and one site in Sakai this week. The Pfizer lot number was identified by the officials as FF5357.
They said that the Pfizer doses containing foreign matter were not used.
Several weeks ago, the Japanese Health Ministry suspended 1.63 million doses of Moderna’s COVID-19 vaccine due to contamination. Weeks later, government officials in early September confirmed that three people died after receiving a shot from the since-suspended batches of Moderna’s vaccine, which uses similar mRNA technology as Pfizer’s.
An investigation later revealed that stainless steel particulates had contaminated the Moderna doses. The two firms traced it back to a production site in Spain.
“Stainless steel is routinely used in heart valves, joint replacements, and metal sutures and staples. As such, it is not expected that injection of the particles identified in these lots in Japan would result in increased medical risk,” the companies said in their statement.
“The rare presence of stainless steel particles in the Moderna COVID-19 vaccine does not pose an undue risk to patient safety and it does not adversely affect the benefit/risk profile of the product,” Takeda Pharmaceutical said in a joint statement with Moderna in late August. Takeda, a Moderna partner, distributes the vaccine in Japan.
Moderna and Takeda, meanwhile, said they would recall several batches of their vaccine due to the contaminants. It’s unclear if Pfizer will initiate a recall.
About 500,000 people have received shots from the three suspended Moderna batches, Taro Kono, Japan’s minister in charge of the vaccination campaign, told reporters on Friday. Moderna said it cannot confirm how many doses were distributed from the batches.
